BNT314

BIOLOGICAL4 trials

Sponsors

BioNTech SE

Conditions

Advanced Malignant Solid TumorAdvanced or metastatic malignant solid tumorsMetastatic Colorectal CancerMetastatic colorectal cancer

Phase 1

Safety and Preliminary Efficacy of BNT314 in Cancer Patients With Malignant Solid Tumors

Active, not recruitingNCT06150183

BioNTech SEAdvanced Malignant Solid Tumor

Start: 2023-11-30End: 2028-03-01Updated: 2026-01-23

A first-in-human, open-label, dose escalation trial with expansion cohorts to evaluate the safety and preliminary efficacy of BNT314 as monotherapy in patients with advanced malignant solid tumors

Active, not recruitingCTIS2023-506053-38-00

BioNTech SEAdvanced or metastatic malignant solid tumors

Start: 2024-08-27Target: 43Updated: 2025-06-16

A Clinical Study to Test if an Investigational Treatment Called BNT314 When Used in Combination With Another Investigational Treatment BNT327 and Chemotherapy, is Beneficial and Safe for Patients With Advanced Colorectal Cancer

RecruitingNCT07079631

BioNTech SEMetastatic Colorectal Cancer

Start: 2025-07-18End: 2031-05-01Target: 482Updated: 2026-03-06

A Phase I/II, randomized, multi-site trial to investigate the efficacy and safety of BNT314 in combination with BNT327 and chemotherapy in participants with metastatic colorectal cancer

RecruitingCTIS2025-521768-36-00

BioNTech SEMetastatic colorectal cancer

Start: 2026-01-27Target: 168Updated: 2025-10-22

Related Papers

A phase 1/2, randomized, global trial to investigate efficacy and safety of EpCAM × 4-1BB bsAb (BNT314/GEN1059) in combination with pumitamig (BNT327; PD-L1 × VEGF-A bsAb) and chemotherapy in patients with metastatic colorectal cancer (mCRC).

Journal of Clinical Oncology2026-01-10